[ EDITORIAL ]

Deadly Drug Errors: Regulate Lethal Compounds

Published: Tuesday, October 23, 2012 at 12:01 a.m.

Last Modified: Tuesday, October 23, 2012 at 12:00 a.m.

If Congress wants to investigate the need for federal regulation of the booming U.S. drug-compounding-lab industry, Ocala in North-Central Florida would be the logical place.

Ocala has repeatedly grabbed headlines over the past three years for the disastrous, even lethal, results of drug-compounding-lab errors.

The first incident came in 2009, when 21 polo ponies perished after ingesting a mineral supplement mixed by an Ocala compounding lab. This year, the same lab came under new scrutiny when 33 cases of a rare fungal eye infection were reported across seven states, leading to blindness in some of the victims.

Now comes the fungal meningitis outbreak emanating from the New England Compounding Center in Framingham, Mass., which, reports the Centers for Disease Control and Prevention, has claimed at least 233 victims, including 15 deaths in 15 states. Three of those deaths occurred in Marion County, the home of Ocala.

As the Tampa Bay Times put it, Ocala has become "the epicenter of pain in Florida."

No more evidence should be necessary for Congress to move to put compounding labs under the regulatory eye of the U.S. Food and Drug Administration.

Compounding labs originally were allowed to operate without federal regulation because they presumably mixed only medicines that were customized for individual patients, who might have an allergy or require a special component. A prescription for each compound is supposedly required.

But, thanks to growing demand and drug shortages, compounding labs are a booming business that caters to far more than just individual prescriptions. New England Compounding produced nearly 18,000 doses of the pain medication that led to the fungal meningitis outbreak.

FDA THWARTED

The FDA has repeatedly tried to rein in the industry, only to be rebuffed by the courts or outlobbied in Congress by the International Academy of Compounding Pharmacists.

As a result, regulation is left to the states, which typically do not have the know-how or resources to police the labs adequately. Imprecise or contaminated drugs have caused more than two dozen deaths since 2000, not including those tied to the current fungal meningitis outbreak.

Former FDA Commissioner David Kessler warned Congress in 1996 that, left unregulated, small drug-compounding outfits could morph into "a shadow industry" producing untested and unsafe drugs that "could result in serious adverse effects, including death."

His warning was on target. Congress should give the FDA the power to oversee compounding labs.

<p>If Congress wants to investigate the need for federal regulation of the booming U.S. drug-compounding-lab industry, Ocala in North-Central Florida would be the logical place.</p><p>Ocala has repeatedly grabbed headlines over the past three years for the disastrous, even lethal, results of drug-compounding-lab errors.</p><p>The first incident came in 2009, when 21 polo ponies perished after ingesting a mineral supplement mixed by an Ocala compounding lab. This year, the same lab came under new scrutiny when 33 cases of a rare fungal eye infection were reported across seven states, leading to blindness in some of the victims.</p><p>Now comes the fungal meningitis outbreak emanating from the New England Compounding Center in Framingham, Mass., which, reports the Centers for Disease Control and Prevention, has claimed at least 233 victims, including 15 deaths in 15 states. Three of those deaths occurred in Marion County, the home of Ocala.</p><p>As the Tampa Bay Times put it, Ocala has become "the epicenter of pain in Florida."</p><p>No more evidence should be necessary for Congress to move to put compounding labs under the regulatory eye of the U.S. Food and Drug Administration.</p><p>Compounding labs originally were allowed to operate without federal regulation because they presumably mixed only medicines that were customized for individual patients, who might have an allergy or require a special component. A prescription for each compound is supposedly required.</p><p>But, thanks to growing demand and drug shortages, compounding labs are a booming business that caters to far more than just individual prescriptions. New England Compounding produced nearly 18,000 doses of the pain medication that led to the fungal meningitis outbreak.</p><p><b>FDA THWARTED</b></p><p>The FDA has repeatedly tried to rein in the industry, only to be rebuffed by the courts or outlobbied in Congress by the International Academy of Compounding Pharmacists.</p><p>As a result, regulation is left to the states, which typically do not have the know-how or resources to police the labs adequately. Imprecise or contaminated drugs have caused more than two dozen deaths since 2000, not including those tied to the current fungal meningitis outbreak.</p><p>Former FDA Commissioner David Kessler warned Congress in 1996 that, left unregulated, small drug-compounding outfits could morph into "a shadow industry" producing untested and unsafe drugs that "could result in serious adverse effects, including death."</p><p>His warning was on target. Congress should give the FDA the power to oversee compounding labs.</p>